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Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897427
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 23, 2022
Sponsor:
Collaborators:
Cancer Prevention Research Institute of Texas
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Erich Sturgis, Baylor College of Medicine

Study Description
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Brief Summary:
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and anogenital cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies or circulating HPV DNA may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.

Condition or disease Intervention/treatment
Human Papillomavirus Infection Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography

Detailed Description:

PRIMARY SCIENTIFIC OBJECTIVES:

I. To determine the association of antibodies to human papillomavirus type 16 (HPV16) early (E) antigens and circulating HPV16 DNA (cHPVDNA) with oral HPV16 prevalence.

II. To determine the association of antibodies to HPV16 E antigens and/or cHPVDNA with site-specific HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).

III. To determine the association of 12-month persistence of oral rinse HPV16 DNA with site-specific oropharyngeal HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).

EXPLORATORY SCIENTIFIC OBJECTIVE:

I. To explore the use of a blood-based point-of-care assay to determine HPV16 E antibody serologic status.

OUTLINE:

STAGE I: Participants undergo collection of blood and oral rinse samples.

STAGE II: Participants complete a head and neck exam with swab of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years.

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 28, 2027
Estimated Study Completion Date : March 28, 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Screening (specimen collection, HPV testing)

STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples.

STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, penile exam, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years. Select participants will provide oral rinse sample by mail every six months.

 Other: Biomarker Analysis
Complete HPV testing

Procedure: Biospecimen Collection
Undergo collection of blood and oral gargle samples

Procedure: Ultrasonography
Undergo transcervical ultrasonography
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US


Outcome Measures
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Primary Outcome Measures :
  1. Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]
    Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.

  2. Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]
    Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants willing to have HPV test
Criteria

Inclusion Criteria:

  • Stage 1 Inclusion Criteria: United States (US) resident
  • Stage 1 Inclusion Criteria: Fluent in English
  • Stage 1 Inclusion Criteria: Sign an approved informed consent document

  • Stage 2 (longitudinal study) Inclusion Criteria:

    • Eligible for and enrolled in Stage 1
    • Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
    • Sign an approved informed consent document

Exclusion Criteria:

  • Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
  • Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
  • Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
  • Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
  • Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
  • Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
  • Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab and oral rinse at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897427


Contacts
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Contact: Giselle Santillana (713) 798-3261 giselle.santillana@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Giselle Santillana    713-798-3261    hpvtrial@bcm.edu   
Principal Investigator: Erich Sturgis, MD, MPH         
Sponsors and Collaborators
Baylor College of Medicine
Cancer Prevention Research Institute of Texas
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Erich M. Sturgis Baylor College of Medicine
More Information
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Additional Information:

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Responsible Party: Erich Sturgis, Professor and Vice-Chair of Clinical Affairs, Dept of Otolaryngology-Head and Neck Surgery; Brown Foundation Endowed Chair; Head, Neck, & Thyroid Cancer Multidisciplinary Program Director, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02897427    
Other Study ID Numbers: BCM H-49215
NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
H-49215 ( Other Identifier: Baylor College of Medicine )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erich Sturgis, Baylor College of Medicine:
HPV
HPV-related oropharyngeal cancer
cancer screening
HPV-related cancers
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections